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Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)
19recalls in 12 months (690 all time)
680recalls that name a 510(k)
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Top companies in HSB

DateFirm and productCodeLinked 510(k)
Feb 28, 2013Orthofix, Inc
Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
Terminated
HSBK010322
K031219
Nov 6, 2012Zimmer, Inc.
Sirus intramedullary nail for tibia, cannulated
Terminated
HSBK043270
Nov 5, 2012OrthoPediatrics Corp
Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended
Terminated
HSBK024173
Jul 23, 2012Synthes USA HQ, Inc.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length
Terminated
HSBK103002
Jul 23, 2012Synthes USA HQ, Inc.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length
Terminated
HSBK103002
Jul 16, 2012Stryker Howmedica Osteonics Corp.
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Driv
Terminated
HSBK020384
May 2, 2012Wright Medical Technology Inc
VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotal
Terminated
HSBK090857
May 2, 2012Wright Medical Technology Inc
VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal
Terminated
HSBK090857
Apr 30, 2012Biomet, Inc.
REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An intramedullary fixa
Terminated
HSBK050118
Apr 16, 2012Integra LifeSciences Corp.
Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for eas
Terminated
HSBK050882
Apr 2, 2012Acumed LLC
The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is label
Terminated
HSBK951740
Nov 8, 2011Stryker Spine
Stryker Mantis Rod Inserter Assembly Manufactured by: Stryker Spine SAS Z. I. Marticot - 33610 - Cestas France; Distributed in the USA by: Stryker Spine 2 Pearl Court. Allendale, NJ 07401-1677 USA S
Terminated
HSBNone listed
Mar 2, 2011Pega Medical Inc.
Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.
Terminated
HSBK020885
K041393
Dec 28, 2010Zimmer Inc.
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter Long, Catalog 00-2490-003-50, Zimmer, Warsaw, IN. A reusable surgical instrument used for the insertion of a Lag Screw used in the Zimme
Terminated
HSBK091566
Nov 9, 2010Stryker Howmedica Osteonics Corp.
Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The nail holding Screw is used to assemble the nail to the t
Terminated
HSBNone listed
Nov 9, 2010Stryker Howmedica Osteonics Corp.
External Compression Device; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Active Apposition/compression is achieved by thread
Terminated
HSBNone listed
Nov 2, 2010Integra LifeSciences Corporation
Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package. The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot
Terminated
HSBK050882
Sep 2, 2010Stryker Howmedica Osteonics Corp.
Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees; Sterile, TI Alloy, Implant; Catalog number 3225-0360S. Stryker Trauma GmbH, 24232 Schenjrchen, Germany; distributed in USA by Howmedica Osteonic
Terminated
HSBK034002
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-086. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-085. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-084. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-083. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-082. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-081. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-076. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-075. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-074. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-073. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-072. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-071. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 34 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-036. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 32 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-035. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-034. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 28 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-033. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-032. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 8mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-031. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 30 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-026. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 28 cm, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-025. The system is used for pediatric and small stature adult patients to stabilize fractures o
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 26 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-024. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 24 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-023. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 22 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-022. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 12, 2010Orthopediatrics Corp
Orthopediatrics IM Femoral Nail - 7mm x 20 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-021. The system is used for pediatric and small stature adult patients to stabilize fractur
Terminated
HSBK083726
May 10, 2010Acumed LLC
Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR
Terminated
HSBK031438
Mar 22, 2010Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200.
Terminated
HSBK021008
Mar 22, 2010Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200.
Terminated
HSBK021008
Mar 22, 2010Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200.
Terminated
HSBK021008
Mar 22, 2010Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170.
Terminated
HSBK021008
Mar 22, 2010Advanced Orthopaedic Solutions Inc
AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200.
Terminated
HSBK021008

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